Study Overview:

Conducting clinical studies for monoclonal antibodies (MABs) involves meticulous planning and execution, especially for recombinant humanized mAbs administered via intravenous (i.v.) infusion. This Recombinant humanized mAb targets subdomain II of the human epidermal growth factor receptor 2 protein (HER2), and it is indicated for use in Metastatic Breast Cancer (MBC) and Early Breast Cancer (EBC) in combination with other mAbs or chemotherapy agents

This blog focuses on a single-dose study to evaluate pharmacokinetic (PK) and immunogenicity endpoints of a recombinant humanized mAb which was administered via intravenous (i.v) infusion to Healthy subjects.

Study Design:

• Double-Blind, Single Dose, Parallel Study
• Blood Sample Collections for PK & Immunogenicity Assessment

Selection & Safety Parameters for Study Subjects:

• Screening Process:
  • The screening of study subjects included clinical examinations, ECG, chest X-ray, echocardiogram, TMT, and various laboratory tests, including cardiac markers.
• Observation and Monitoring
  • Subjects were housed under the observation of intensivists / MD medicine specialists / Cardiologists to ensure their safety.
  • Continuous cardiac monitoring during the IMP administration via intravenous infusion.
  • All lifesaving drugs were readily available in the form of an emergency tray in the ward area, ensuring immediate response to any adverse events.

Key Challenges and Considerations

Discover how we tackled and conquered various challenges in our study, implementing effective solutions for a successful outcome.

Large Sample Size with Sentinel Dosing Approach in Multiple Group

The sentinel dosing approach, where initial small cohorts received the MAB before larger groups, ensuring early detection of adverse reactions, and enhancing the safety profile of the study.

Stringent Subject Selection Criteria

Rigorous criteria for subject selection were followed, including comprehensive health screenings, clinical examinations, ECG, chest X-rays, echocardiograms, treadmill tests (TMT), and various laboratory tests, including cardiac markers.

Handling Logistics for Accurate IMP Administration

Accurate administration of the investigational medicinal product (IMP) involved meticulous planning for dispensing, dilution, flow rate, administration time, and managing void volume.

Comprehensive Subject Follow-Up Plan

Considering the study duration of over three months, a detailed follow-up plan was developed. This included scheduling multiple ambulatory visits to monitor the subjects’ health and collecting necessary data, ensuring adherence to the study protocol.

Monitoring the Safety of the Subjects

Continuous monitoring of subjects’ safety involved regular clinical assessments, ensuring the availability of lifesaving drugs in the ward area, and multiple ECG recordings during the housing and throughout the study.

Effective SAE Management

Developed a comprehensive SAE management protocol plan including clear escalation procedures and continuous training for study staff. Ensured immediate access to emergency medical interventions and continuous observation by intensivists, MD medicine specialists, or cardiologists during SAE Management.

Conducting a single-dose study with pharmacokinetic and immunogenicity endpoints for a Recombinant Humanized mAb involved several critical considerations. From stringent subject selection to meticulous planning of IMP administration and continuous safety monitoring, each step was vital for the success of the study.

Extensive Experience

Our highly specialized team, composed of global experts in early development and clinical pharmacology, meticulously designs an integrated early-phase program. We possess extensive experience in conducting a variety of studies, ranging from first-in-human to drug-drug interaction, enabling informed decisions. This includes first-in-human (FIH), proof-of-concept, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), biosimilar, and various pharmacokinetic (PK), single ascending dose/multiple ascending dose (SAD/MAD) studies. Leveraging our advanced facilities, operational expertise, and wealth of clinical development experience, we ensure the precise execution of your clinical trials involving patients and/or healthy volunteers.

Connect with our experts at [email protected] to leverage the extensive end-to-end capabilities of Lambda Therapeutic Research & Novum Pharmaceutical Research Services having global footprint across India, USA and Canada.